Xinlitai's new drug "tegrilol" came out, and the antithrombotic 30 billion market ushered in a new round of reshuffle

Recently, Shenzhen xinlitai Pharmaceutical Co., Ltd received the approval document for drug registration of tegrilol tablets approved and issued by the State Drug Administration The board of directors of the company released a notice on the evening of August 2, 2018, disclosing this exciting news to the society In recent days, under the hot summer and stormy weather from south to north, it has added new vitality to the domestic pharmaceutical industry In the announcement, the basic information of the approval document for drug registration is: chemical drug category 4, tegrilol tablet, specification 90mg, drug approval No is gjzz h20183320, and the validity period of the drug is 24 months Examination and approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, this product meets the relevant requirements of drug registration, approves the registration and issues the drug approval number With the high level of cardiovascular disease in the world, the market of antithrombotic drugs is gradually warming up According to the data, the global antithrombotic market reached US $23.5 billion in 2017 and is expected to reach US $25.9 billion in 2018 In the current antithrombotic drugs, antiplatelet aggregation drugs play an important role After entering the 21st century, antithrombotic drugs at home and abroad have developed into a new era from research and development pipeline to market platform Tigrerolol is a direct acting, reversible combination of P2Y12 platelet inhibitor, which is used in patients with acute coronary syndrome (unstable angina, non ST elevation myocardial infarction or ST elevation myocardial infarction), including patients receiving drug treatment and PCI treatment, to reduce the incidence of thrombotic cardiovascular events The product belongs to class B scope of national basic medical insurance catalogue (2017 Edition) none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; The incidence rate of cardiovascular disease is high, the rate of disability is high, the mortality rate is high, the recurrence rate is high, and the complications are many According to the results of the third national death cause survey released by the Ministry of health of China, cerebrovascular diseases have accounted for 22.45% of the total deaths There are 2.5 million new stroke cases in our country every year With the improvement of the treatment level, the survival rate has been improved But 70% of the patients still have the sequelae of memory, facial and limb nerves Stroke has become the primary factor affecting the quality of life of the elderly Under the rigid demand, antithrombotic drugs are full of infinite vitality In recent years, the green channel of CDE has accelerated the review and listing of new drugs; pradaxa (tibaiquan), Bayer (xarlto), AstraZeneca (brinta) and Bristol (eliquis) have been successively approved The registration of new drugs in China, these drugs have quickly seized the market after listing, so as to meet the needs of the domestic antithrombotic treatment market According to the latest data of minenet, in 2017, the antithrombotic drug market of public hospitals in key cities in China was 3.623 billion yuan, up 7.37% year on year, a new high in recent years The top 10 varieties of antithrombotic sales accounted for more than 90%, which were clopidogrel, low molecular weight heparin, troxerutin cerebroprotein hydrolysate, rivaroxaban, beprost sodium, enteric aspirin, tegrilol, ateplase, dabigatran ester, heparin, etc (see Table 1) Shenzhen xinlitai Pharmaceutical Co., Ltd has been approved as a domestic tegrilo, which will usher in another reshuffle of antithrombotic drug market Table 1: Top 10 antithrombotic drug markets of public hospitals in key cities in China in 2017 (unit: 10000 yuan;%) none = "shifumousedownstyle ('shifu bus_002 ')" style = "margin: 1em Auto; padding: 0px; max width: 100%; font family: apply system font, BL inkmacsystemfont," Helvetica Neue "," Pingfang SC "," hiragino sans GB "," Microsoft YaHei UI "," Microsoft YaHei ", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> tegrilol has a growth rate of 59.02% Tegrilol is a new and selective small molecule anticoagulant developed by AstraZeneca It is the first reversible binding, direct acting, oral administration of a new P2Y12 receptor antagonist In July 2011, it was approved by the FDA of the United States and listed under the trade name of brilinta In December 2012, tegrilo of AstraZeneca entered the Chinese market, with the commodity name of "beilinda" In 2017, brinta has become a global blockbuster drug Tegrelol is mainly used in the prevention and treatment of cardiovascular and cerebrovascular thrombotic events to reduce the incidence of thrombotic cardiovascular events The Plato study also showed that tegrarol was more effective than clopidogrel It has been recommended by 10 international treatment guidelines for patients with acute coronary syndrome According to the latest data of mienei.com, in 2017, the sales volume of tegrilo, a public hospital in key cities in China, exceeded 100 million yuan, with a year-on-year growth rate of 19.20%, which is one of the fast-growing varieties From a global perspective, anticoagulants have always been a competitive market for major pharmaceutical companies In this segment, aspirin is a senior anticoagulant and is used as a primary preventive drug in clinical practice Clopidogrel, which was launched in 1997, is another blockbuster anticoagulant after aspirin, with annual sales peaking at nearly $10 billion Tegrarol is a new generation of clopidogrel It does not need to be activated by liver metabolism It has stronger inhibition and faster effect on platelets, and can significantly reduce the incidence of cardiovascular death, myocardial infarction or stroke Since its launch, tegrarol has been recommended as the first-line or preferred antiplatelet drug for ASC patients by many European and American treatment guidelines Recently, Shenzhen xinlitai tegrilol tablet approved by the State Drug Administration is the first new drug in China Up to now, more than 30 domestic applications have been submitted for registration of tegrilol, 16 of which have been approved for clinical application and are in the state of review, with the potential of wind and rain The exclusive product of AstraZeneca tegrilo has exceeded the market scale of 500 million yuan in China In 2017, the Ministry of human resources and social security of the people's Republic of China announced that tegrilol negotiated to enter the medical insurance catalog The negotiation price was reduced by 22.78% compared with the lowest price of hospital bidding, and tegrilol (90mg) was reduced from the original 10.94 yuan / tablet to 8.45 yuan / tablet After the listing of Shenzhen xinlitai tegrilo film, the market of tegrilo has been continuously promoted under the situation of rigid demand none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> clopidogrel is still the leader In the late 1990s, the FDA of the United States approved the listing of clopidogrel, a platelet aggregation inhibitor It was developed and sold by Bristol Myers Squibb and Sanofi Aventis in the global market, becoming a milestone in the field of antithrombotic and antiplatelet aggregation Clopidogrel was developed and listed earlier in China In 2000, China's CFDA first approved the registered production of clopidogrel by Shenzhen xinlitai Pharmaceutical Co., Ltd under the trade name of "Taijia" On September 19 of the same year, clopidogrel of Sanofi Aventis and Bristol Myers Squibb was granted administrative protection in China In 2001, clopidogrel of Sanofi Aventis was approved to be listed in China under the trade name of "Plavix" With the advent of aging society in China, the rapid development of cardiovascular and cerebrovascular interventional therapy in China, the simultaneous follow-up of anticoagulation, antiplatelet agglutination and hypolipidemic therapy after interventional therapy, has driven the market of clopidogrel to develop in depth, which is now the first variety of antithrombotic market, and also an irreplaceable basic drug in the treatment of acute coronary syndrome According to the latest data of minenet, in 2017, the sales volume of clopidogrel in public hospitals in key cities reached 1.539 billion yuan, an increase of 0.65% over the previous year Sanofi Aventis accounted for 58.90%, Shenzhen xinlitai for 34.36% and Lepu pharmaceutical new Shuaike for 6.75%   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> the leader, rivaroxaban, is the first direct oral XA factor inhibitor listed by Bayer / Johnson in the world In March 2009, it was approved by CFDA for registration, and the trade name is bairituo Indications for the prevention and treatment of deep vein thrombosis, it is mainly used to prevent the formation of deep vein thrombosis and pulmonary embolism in patients after hip joint and knee joint replacement It can also be used to prevent stroke and non central nervous system embolism in patients with non valvular atrial fibrillation, and reduce the risk of recurrence and stroke of coronary syndrome In 2017, the global market generated US $5.798 billion in sales, an increase of 16.29% over the previous year According to the latest data of mienei.com, in 2017, the sales volume of public hospitals in key cities in China was 270 million yuan, an increase of 23.43% over the previous year In the antithrombotic market, it has become the biggest threat of low molecular weight heparin products Especially after the promulgation of the national medical insurance catalogue in 2017, rivaroxaban added "limited warfarin for the treatment of non valvular atrial fibrillation patients with poor control or high risk of bleeding" on the basis of the indications originally limited for lower extremity joint replacement surgery, so that rivaroxaban has a new development space In 2017, eight new products of antithrombotic drugs, dabigatran ester, tegrilol, apixaban, sulodette, agatroban, etibatide, indobufen and fondagangui, were added to the medical insurance catalogue, which also intensified the market competition of the same variety and showed a white hot trend none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-family: -apple-system-font, Bl inkMacSyst